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Buffalo-formed company Athenex gets FDA approval for pre-cancerous skin lesions drug

Posted at 4:58 PM, Dec 15, 2020

BUFFALO, N.Y. (WKBW) — Thirty million American suffer from a condition called Actinic Keratosis, a pre-cancerous skin lesion. It's the second most common diagnosis made by dermatologists.

If left untreated, ten to 15 percent of these lesions will develop into skin cancers.

"Actinic Keratosis afflicts primarily fair-skinned people that have a lot of sun exposure. So what happens is you get a red scaly and crusty lesion," said Dr. Daniel Lang, Senior Director of Corporate Development at Athenex.

Buffalo-formed biopharmaceutical company Athenex just got FDA approval for a topical ointment to treat it, called Klisyri.

"We demonstrated against a placebo control clinical study that was randomized, with only five days of treatment, Klisyri was able to achieve 100 percent clearance in 50 percent of the patients," said Dr. Lang.

The drug treats AK that appears on the face or scalp. It should be used once a day for five days.

"This is a gigantic win. This is, it's one of the first FDA drugs ever to come out of Buffalo, and we're so proud of our origins," said Teresa Bair, Senior V.P. at Athenex.

Compared to competitors - whose drugs require 2 to 3 months of applications on a daily basis, Dr. Lang said Klisyri is much better tolerated by patients.

"These are chemotherapy that has been reformulated into a topical ointment, and you're essentially putting chemotherapy on your skin," said Dr. Lang

But the most common adverse reactions were discomfort and application site pain.

"If we all look around at our parents and our grandparents, many of them have Actinic Keratosis, and they're going to be thrilled for this product," said Bair.

Klisyri will be launched in the US in the first quarter of 2021.

In addition, Bair said Athenex's pharmaceutical manufacturing plant in Dunkirk is nearly complete and equipment is being brought in. They intend to be fully operational in mid 2021.